ComplianceOnline

IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER

Instructor: E.J Smith
Product ID: 700956
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2008

Training CD / USB Drive

$500.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This presentation covers all of the steps one should take when beginning the IDE process for a PMA.

The most important step in the PMA process is the IDE for your clinical trial(s). This presentation covers all of the steps one should take when beginning the IDE process for a PMA. Emphasis is placed on protocol.

Areas Covered in the seminar:

  • Getting Stated.
  • Meetings with FDA.
  • Sample Size Considerations.
  • Inclusion/Exclusion Criteria.
  • End Points.
  • Contraindication, Precautions, Cautions, Adverse Events.
  • Case Report Forms.
  • Administrative Plan.

Who will benefit:

This webinar is directed at any company that will have to perform a clinical trial to support their safety and effectiveness claims.

  • Sponsor
  • Regulatory Manager
  • Clinical Specialist
  • Venture Capitalist

Instructor Profile:

E.J. Smith, is a co-founder of Smith Associates, a FDA regulatory consulting firm that specializes in the preparation of 510(k), PMA and IDE submissions, device and cosmetic labeling, quality system audits and clinical trials. E.J. is the author of Hospital Consumables and Smith’s Reference and Illustrated Guide to Surgical Instruments and has 43 years of experience in medical marketing, executive positions and FDA regulatory affairs.

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria..Credit available for Live webinar Attendees only.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews Write review

This presentation was better than most I have attned. Comprehensive coverage in 1 hour with lots of "tidbits".
- Anonymous

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